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Benefits of Contract Manufacturing and How to Choose the Right Contract Manufacturing Service

Whether you’re new to medical device diagnostics manufacturing or are looking to scale up production of your current product line, contract manufacturing is an option you may well have considered, and for good reason. Outsourcing your manufacturing processes, or even your R&D process, to a contract manufacturer can benefit your company in a number of ways. But there are also some things to remember to make sure you select the best contract manufacturer (CM) for your business.

First, let’s talk about the benefits of contract manufacturing. At the end of the day, companies hire contract manufacturers for the time and cost savings. Working with a contract manufacturer can save you overhead costs. CM services like SafePath Laboratories and its sister company IVD Research are existing facilities, meaning they already have the space and equipment you’ll need, as well as the proper licensing and/or registration. Contract manufacturing can also help you save time and money on hiring, as CMs already have highly qualified, trained production as well as research and development staff.

Finally, you’ll benefit from a CM’s existing expertise instead of having to learn everything yourself. Well-established manufacturers like SafePath and IVD Research know exactly what you’ll need, or will know how to quickly find the answers, in order to develop, produce and license your product. They’ll be able to walk you through proper research and development procedures, help you set up and run clinical trials, and make sure you can successfully navigate an increasingly complex regulatory environment.

As we mentioned before, though, there are some important factors to remember when choosing a contract manufacturing service.

The success of a contract manufacturing relationship depends on the fit – you need to make sure the contract manufacturer you hire is the best fit for your business’s specific needs. While it may seem impressive to sign on with a “Tier 1” manufacturing service provider, this is not necessarily your best option. If you have a very large order to place, then by all means, go with a large CM. Otherwise, you’ll want to look for a CM that can best handle the size of the manufacturing job you actually have. If you have a smaller job, this may mean it’s best to look for a smaller CM so you don’t end up being a small fish in a big pond.

Another important piece of the fit are the people with whom you’ll actually be working. Ideally, you want a management team and staff who are friendly, easy to work with, and responsive. Look for a CM service provider whose management style, company culture, and business model meshes with your own. You’ll also want a company that offers flexibility and is willing to work with you to find the right solution to get you the highest quality product at the lowest possible cost. It’s key to get to know the people who’ll actually be working on your product, so make sure you talk to your CM’s operations team, not just their sales and marketing team.

This goes hand-in-hand with vetting potential CMs’ experience and expertise in diagnostics manufacturing. How long has the company been around? What types of products do they manufacture? How long have they been engaged in contract manufacturing in your particular niche? For example, SafePath and its sister company, IVD Research, have offered contract manufacturing services since 1996. Over the past two decades, we have helped our contract manufacturing clients produce dozens of medical devices, from simple buffer preparation all the way to finished licensed devices and everywhere in between. At the same time we’ve developed and manufactured our own line of diagnostic testing products.

In addition to a CM’s longevity and experience in your field, you also want a company with high standards. For medical device manufacturing, this means certification and traceability.

CM facilities should be registered and certified in the standards that are applicable to your need. SafePath is a USDA Licensed Biologics Manufacturer, while IVD Research is FDA registered, follows cGMP (current Good Manufacturing Practices) guidelines, and is ISO 13485:2003 certified.

Traceability also matters when someone else is handling your product. You want your contract manufacturer to use a thorough ERP/MRP system to track inventories, by lot number, of all raw materials, sub-assemblies, and finished goods. Your CM should also be able to provide you reports on these inventories at any time so you have a full understanding of the status of your project.

Finally, the last piece of the puzzle is you. Contract manufacturing relationships don’t just manage themselves, and finding a contract manufacturing service provider you love in the beginning is no guarantee that a project will go well or stay on budget. Establish a good, transparent working relationship with your contract manufacturer, and make sure that your own operations are organized to effectively and actively manage your contract manufacturing projects.

About SafePath

A qualified team of professionals with over 30 years of experience, and a proven record of innovation, in the development, manufacture, and marketing of high performance immunoassays.

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